A Phase 3 interventional study of Alfuzosin in Prostatic Hyperplasia, sponsored by Sanofi. Terminated at 1 site in Portugal. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-09-24.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 220 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety: General clinical safety by collection of spontaneously reported adverse events
Time frame: at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
Time frame: 72h to 96 hours after ESWL
Percentage of patients without imagiologic evidence of any stone
Time frame: 24 hours after ESWL
Percentage of patients with clinical evidence of stones clearance
Time frame: 72h to 96 hours after ESWL
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores
Time frame: at 24h, (48h, if applicable), 72-96h and 7 days
Need for rescue analgesic medication.
This study is terminated, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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Sanofi